| Class 2 Device Recall PIP FIXATION HINGE | |
Date Initiated by Firm | January 23, 2009 |
Date Posted | September 15, 2009 |
Recall Status1 |
Terminated 3 on July 29, 2013 |
Recall Number | Z-2027-2009 |
Recall Event ID |
52617 |
510(K)Number | K994143 |
Product Classification |
external fixation of finger joint - Product Code JDW
|
Product | Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint. |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
|
For Additional Information Contact | Victor Rocha 901-399-6771 |
Manufacturer Reason for Recall | Hinge failure: The product is cracking or breaking during use. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118 |
Quantity in Commerce | 7,089 units |
Distribution | Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JDW
|
|
|
|